]>
IRCT20191023045206N1 IRCT 2020-05-06 Ahvaz University of Medical Sciences Dexmedetomidine versus remifentanil in post operative pain control after spine surgery Comparing the effect of Dexmedetomidine and Remifentanil on post operative pain control after spine surgery 2019-12-01 anticipated 60 Complete https://irct.ir/trial/44144 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: In this study spinal surgery patients will be devided to two groups recieving dexmedetomidine and remifentanile in random using random digits table, Blinding description: The anesthesiologist who has responsible for the patients management of anesthesia will administer the medicine (s) via coded syringes had been prepared previously and will not aware of the injected drug (dexmedetomidin or remifentanile), and anesthesia nurse who is responsible for collection of patients information and study variables is unaware of the administered drug will record the check- list during surgery and in the recovery. Also the patient is unaware of the injected medicine. 3 Post operative pain. Intervention 1: Intervention group1:serum ringer lactate 5 ml/kg,midazolam 0.02 mg/kg,fentanyl 2mcg/kg,propofol1.5 mg/kg,atracuriom 0.5 mg/kg,morphine sulfate 0.1 mg/kg for induction and dexmedetomidine0.1mcg/kg in 10 minutes(Abureyhan _Iran co.) and for maintnance propofol 100 to 150 mcg/kg besides dexmedetomidine0.1mcg/kg/h will recieve. Intervention 2: Intervention group2:serum ringer lactate 5 ml/kg,midazolam 0.02 mg/kg,fentanyl 2mcg/kg,propofol1.5 mg/kg,atracuriom 0.5 mg/kg,morphine sulfate 0.1 mg/kg for induction and remifentanile bollus dose(Abureyhan _Iran co.) 1 mcg/kg and for maintnance propofol 100 to 150 mcg/kg besides 1 mcg/kg/min remifentanile will recieve. Yes - There is a plan to make this available What will be shared: data after the end of study will be avalable. When: from 2021 To whom: physicians Conditions: using for future studies. Where to obtain: send E-Mail to Mohammad.zafari2@yahoo.com How to obtain: filling the study reguest form Comments:
public Farahzad Janatmakan
Golestan avenue
Ahwaz Iran (Islamic Republic of) 6136766337 +98 61 3374 8388 janatmakan-f@ajums.ac.ir Ahvaz University of Medical Sciences scientific Nozar Nassajian
Golestan avenue
Ahwaz Iran (Islamic Republic of) 6136768831 +98 61 3376 6841 nasajian-n@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Elective surgery of spine age of 18-65 years ASA class 1,2 18 years 65 years Both Previous spine surgery Opium addiction Alcohol addiction Neurological disease Neuromuscular disease Psychological disease Pulmonary disease Cardiovascular disease Analgesic consumer(cox-2 inhibitors) Operative unpredictable events (massive bleeding) R52.9 Pain, unspecified Diagnosis Treatment - Drugs Intervention group1:serum ringer lactate 5 ml/kg,midazolam 0.02 mg/kg,fentanyl 2mcg/kg,propofol1.5 mg/kg,atracuriom 0.5 mg/kg,morphine sulfate 0.1 mg/kg for induction and dexmedetomidine0.1mcg/kg in 10 minutes(Abureyhan _Iran co.) and for maintnance propofol 100 to 150 mcg/kg besides dexmedetomidine0.1mcg/kg/h will recieve. Intervention group2:serum ringer lactate 5 ml/kg,midazolam 0.02 mg/kg,fentanyl 2mcg/kg,propofol1.5 mg/kg,atracuriom 0.5 mg/kg,morphine sulfate 0.1 mg/kg for induction and remifentanile bollus dose(Abureyhan _Iran co.) 1 mcg/kg and for maintnance propofol 100 to 150 mcg/kg besides 1 mcg/kg/min remifentanile will recieve. Pain. Timepoint: 30, 60 and 120 minutes and 24 hours after surgery. Method of measurement: Visual Analogue Scale. Systolic blood pressure variance. Timepoint: 30, 60 and 120 minutes and 24 hours after surgery. Method of measurement: blood pressue monitor. Diastolic blood pressue variance. Timepoint: 30, 60 and 120 minutes and 24 hours after surgery. Method of measurement: blood pressure monitoring. Heart rate variance. Timepoint: 30, 60 and 120 minutes and 24 hours after surgery. Method of measurement: heart rate monitoring. O2 saturation variance. Timepoint: 30, 60 and 120 minutes and 24 hours after surgery. Method of measurement: Pulseoxymetry. Ahvaz University of Medical Sciences Approved 2019-11-16 Ethics committee of Ahwaz University of Medical Sciences Golestan hospital; Golestan avenue Ahwaz Khouzestan Iran (Islamic Republic of)